AB0478 FRENCH REAL-LIFE DATA ON THE 18-MONTH EFFECTIVENESS OF TOFACITINIB ACCORDING TO CONCOMITANT USE OF CSDMARD IN PATIENTS WITH RHEUMATOID ARTHRITIS: INTERIM RESULTS OF THE OBSERVATIONAL STUDY, DEFACTO
Authors: C. Gaujoux-Viala, A. Basch, S. Lassoued, F. Coury-Lucas, M. Kessouri, A. Saighi, Y. Brault, P. A. Squara, T. Lequerre, C. Salliot
Journal: Annals of the Rheumatic Diseases (2023)

<h3>Background</h3> Tofacitinib, an oral JAK inhibitor, is indicated for the treatment of adult patients with moderate to severe active rheumatoid arthritis (RA) for which we have no real-life effectiveness data in a French RA population. <h3>Objectives</h3> To describe tofacitinib effectiveness profile according to concomitant use of csDMARD in a French prospective observational study, DeFacTo. <h3>Methods</h3> DeFacTo, is an ongoing observational study with the primary objective of identifying predictive factors of Tofacitinib maintenance in real-life RA patients. The results described here are based on a descriptive interim analysis of its effectiveness at 18 months. <h3>Results</h3> Among 314 pts enrolled in the study, 301 (POP1) were included in this effectiveness analysis, including 274 (POP2) patients with follow-up ≥ 18 months on 03/15/2022 (date of analysis) with a median exposure duration of 538 [Q1; Q3: 381; 554] days. At baseline, among POP2: 168 (POP3) patients were treated with tofacitinib used concomitantly with at least one csDMARDs vs 106 (POP4) tofacitinib monotherapy. In POP3 vs POP4 respectively, 76.8% vs 84.9% were female, with a mean (± SD) age of 59.5 (10.8) vs 59.9 (12.1), median disease duration of 8.6 years [Q1;Q3: 3.2; 18.6] vs 11.1 [Q1;Q3: 5.3; 19.4)], 40.3% vs 52.4% patients had erosions, 80.5% vs 76.5% had FR+ and 77.7% vs 75.0% had ACPA+. Median CRP was 7.0 [Q1;Q3: 2.9; 18.0] vs 8.0 [Q1;Q3: 3.0; 18.1], and mean DAS28-4 CRP was 4.4 ±1.1 vs 4.7 ±1.0, in POP3 and POP4 respectively. Result showed a decrease in inflammatory markers, pain, and DAS28-CRP activity scores in both groups. At 18 months of follow-up, 24.4% and 24.5% of the pts achieved DAS28-CRP remission in POP 3 and POP 4 respectively (Table 1). Note that missing data and treatment discontinuation were considered as failures which resulted in an underestimation of LDA and remission at 18 months. <h3>Conclusion</h3> This intermediate analysis from real-life study showed that tofacitinib in RA patients is effective with or without csDMARD. <h3>Acknowledgements</h3> This study was sponsored by Pfizer. <h3>Disclosure of Interests</h3> Cécile Gaujoux-Viala Speakers bureau: AbbVie; Amgen; Bristol-Myers Squibb; Celgene; Eli Lilly; Galapagos; Gilead Sciences, Inc.; Janssen; Medac; Merck-Serono; Mylan; Nordic Pharma; Novartis; Pfizer; Roche; Sandoz; Sanofi; and UCB, Consultant of: AbbVie; Amgen; Bristol-Myers Squibb; Celgene; Eli Lilly; Galapagos; Gilead Sciences, Inc.; Janssen; Medac; Merck-Serono; Mylan; Nordic Pharma; Novartis; Pfizer; Roche; Sandoz; Sanofi; and UCB, Andre BASCH Consultant of: Janssen, Novartis, Amgen, BMS, Abbvie, Lilly, Pfizer, MSD, UCB, Slim Lassoued: None declared, Fabienne COURY-LUCAS Consultant of: AbbVie, Bristol-Myers Squibb, Janssen, Lilly, MSD, Novartis and Pfizer, Grant/research support from: AbbVie, Biogen, Roche Chugai, Pfizer, and UCB, Meriem Kessouri Shareholder of: Pfizer, Employee of: Pfizer, Amine Saighi Shareholder of: Pfizer, Employee of: Pfizer, Yves Brault Shareholder of: Pfizer, Employee of: Pfizer, Pierre-Alexandre Squara Shareholder of: Pfizer, Employee of: Pfizer, Thierry Lequerre Consultant of: Abbvie, BMS, Boeringher, Lilly, Medac, MSD, Nordic Pharma, Novartis, Pfizer, Roche – Chugai, Sanofi, UCB, Carine Salliot Consultant of: Biogen, Lilly, Novartis, Roche Chugai, Pfizer.